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FDA 510(k)

POLY-WIRE PISTON

K-Number: K945107 · 1994-11-22

ApplicantMicromed Development Corp.
Decision Date1994-11-22
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POLY-WIRE PISTON is the device name listed in this FDA 510(k) record. The listed applicant is Micromed Development Corp.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K945107. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-WIRE PISTON?

POLY-WIRE PISTON is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Micromed Development Corp.. The 510(k) number is K945107.

When did POLY-WIRE PISTON receive FDA 510(k) clearance?

POLY-WIRE PISTON received FDA 510(k) clearance on 1994-11-22, under 510(k) number K945107.

Who is the listed applicant for POLY-WIRE PISTON?

The FDA 510(k) record lists Micromed Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLY-WIRE PISTON?

The FDA product code for POLY-WIRE PISTON is ETB.

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Other records listing Micromed Development Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945105POLY/PLATINUM WIRE PISTONK945831DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KITK945242NERVE MONITOR ELECTRODES/STIMULATOR PROBESK945108POLY PISTONK945438EDI-BUR MICRODRILL SYSTEMSK945104MICROMED PARTIAL REGULAR AND PARTIAL OFFSET

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Related Devices (Code: ETB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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